Download Alzheimer`s Disease and Related Disorders

Regulatory and Clinical
Considerations for Antipsychotic
Medication Use in the Elderly
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Objectives
• Review the background of antipsychotic use in the
elderly
• Review appropriate and inappropriate use of
antipsychotic medications
• Review side effects and monitoring of antipsychotic
medications
• Review the regulations regarding antipsychotic use
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Background
• 1987- Nursing Home Reform Law
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Background
• 2006- CMS Re-categorization of
Psychotropic F tags
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Background
• 2007- Consumer Advocacy/Political Push
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Background
• 2008- OIG Report, first quantification of
antipsychotic off-label use in SNFs
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2
Background
• 2011- OIG Report
– Raised concerns that antipsychotics were being
prescribed to elderly patients with dementia too
frequently
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Background
• 2102- Partnership to Improve Dementia Care
Initiative
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Background
• 2014- 15% Reduction accomplished
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Background
• 2015- 25% reduction
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Background
• 2016- 30% reduction
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Background
• Statistics
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Background
• Black Box Warning
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
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Antipsychotic Medications
• Class of medicines used to treat serious mental
disorders
• Commonly used to treat both true psychiatric
disorders as well as the behavioral and
psychological symptoms of dementia
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Antipsychotic Medications
• FDA approved indications include*:
– Schizophrenia
– Bipolar disorder
– Tourette’s Syndrome
– Major Depressive Disorder
* FDA indicated uses do not apply to every antipsychotic medication. Refer to Package Insert. This is
not an exhaustive list. Other FDA indications exist that are not applicable to this presentation.
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5
Antipsychotic Medications
• Physicians may prescribe antipsychotic
medications for both FDA approved
indications as well as “off-label” indications,
such as the Behavioral and Psychological
Symptoms of Dementia (BPSD) .
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Antipsychotic Medications
• Common 1st generation antipsychotics:
– Compazine (prochlorperazine)
– Haldol (Haloperidol)
– Loxitane (loxapine)
– Mellaril (thioridazine)
– Prolixin (fluphenazine)
– Thorazine (chlorpromazine)
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Antipsychotic Medications
• 2nd generation (atypical) antipsychotics:
– Abilify (aripiprazole)
– Clozaril (clozapine)
– Geodon (ziprasidone)
– Invega (paliperidone)
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Antipsychotic Medications
• 2nd generation (atypical) antipsychotics:
– Latuda (lurasidone)
– Risperdal (risperidone)
– Saphris (asenapine)
– Seroquel (quetiapine)
– Zyprexa (olanzapine)
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Antipsychotic Medications
• In a skilled nursing facility, antipsychotic
medication should generally be used only for
the conditions/diagnoses listed on the
following slides:
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Antipsychotic Medications
• Schizophrenia and related disorders
• Delusional disorder
• Mood disorders:
– bipolar disorder
– severe depression refractory to other therapies
and/or with psychotic features
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Antipsychotic Medications
• Psychosis
• Medical illness with psychotic symptoms
– brain tumor
– delirium
• Medication related psychosis or mania
– high-dose steroids
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Antipsychotic Medications
• Tourette’s disorder
• Huntington disease
• Hiccups (not induced by other medications)
• Nausea and vomiting associated with cancer
or chemotherapy
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Antipsychotic Medications
• Behavioral or Psychological Symptoms of
Dementia (BPSD)
• Antipsychotics should only be considered for elderly
patients with dementia after medical, physical,
psychological, emotional, social, and environmental
causes have been identified and addressed.
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Antipsychotic Medications:
Use with BPSD
• Many different behavioral and psychological symptoms can
occur in dementia
• Often a result of multiple contributing factors, so evaluation
and treatment must be person centered
• Non-medication, “behavioral modification” is preferred, as
almost all of the medications used to treat behavioral
symptoms have side effects that can increase confusion
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Antipsychotic Medications:
Use with BPSD
• It has been estimated that for every 100 patients
with dementia treated with an antipsychotic
medication, only 9 to 25 will benefit and 1 will die
Schneider LS, Tariot PN, Dagerman KS, et al. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease. N Engl J Med. Oct 12
2006; 355(15):1525-1538.
Schneider, LS et al. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials.
JAMA. 2005; 294:1934-194
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Why an antipsychotic is often
NOT the answer…
• Mrs. Smith is aggressive at bath time:
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Why an antipsychotic is often
NOT the answer…
• Common triggers of aggressive behavior in
the dementia patient:
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Why an antipsychotic is often
NOT the answer…
• Common triggers continued:
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Why an antipsychotic is often
NOT the answer…
• Before an antipsychotic is considered- think about
the resident & what is triggering the behavior :
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Antipsychotic Medications:
Appropriate Uses in BPSD
• Should only be considered when:
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Antipsychotic Medications:
Appropriate Uses in BPSD
• Appropriate treatment targets*:
• Aggressive behavior
• Hallucinations (see or hear things that are not there)
• Delusions (believe something that is not true, such as
thinking someone is trying to hurt you (paranoia))
• Inconsolable or persistent distress
*as defined by CMS guidelines for long term care facilities
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Antipsychotic Medications:
Inappropriate Uses
• Inappropriate treatment targets*:
– Wandering
– Poor self care
– Restlessness
– Impaired memory
– Mild anxiety
*as defined by CMS guidelines for long term care facilities
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Antipsychotic Medications:
Inappropriate Uses
• Inappropriate treatment targets*:
– Insomnia
– Unsociability
– Inattention or indifference to surroundings
– Sadness or crying alone that is not related to
depression or psychiatric disorder
*as defined by CMS guidelines for long term care facilities
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*as defined by CMS guidelines for long term care facilities
Antipsychotic Medications:
Inappropriate Uses
• Inappropriate treatment targets*:
– Fidgeting
– Nervousness
– Uncooperativeness
– Verbal expressions/agitated behaviors which do
not represent a danger to the resident or others
*as defined by CMS guidelines for long term care facilities
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*as defined by CMS guidelines for long term care facilities
Antipsychotic Medications:
Side Effects
• Increased risk of death in elderly patients
with dementia (Black Box Warning)
• Stroke
• Restlessness, pacing, inability to sit still
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12
Antipsychotic Medications:
Side Effects
• Movement Side Effects
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Antipsychotic Medications:
Side Effects
• Weight gain
• Elevated blood sugar
• Increased cholesterol
• Postural (orthostatic) hypotension
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Antipsychotic Medications:
Side Effects
• Swelling
• Sleepiness or sedation
• Increased confusion
• Constipation and difficulty urinating
• Blurred Vision
• Dry mouth
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13
Antipsychotic side effect comparison
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Carnahan R, Reist J, Kelly M, et al. Antipsychotic Use in Dementia. ttps://www.healthcare.uiowa.edu/IGEC/IAAdapt/document/Antipsychotic_Use_in_Dementia.pdf. Accessed: 20 April 2012
Antipsychotic Medications:
Monitoring
• Side effects
• Efficacy
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SNF Regulations
CMS Long Term Care Regulations
• F222- Chemical Restraints
• F309- Quality of Care
• F329- Unnecessary Medications
– Daily dose thresholds for resident’s with
dementia
– Dose reduction requirements
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SNF Regulations
Dose Reduction Requirements
• The purpose of tapering a medication is to find an
optimal dose or to determine whether continued
use of the medication is benefiting the resident.
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SNF Regulations
Dose Reduction Requirements
• Tapering may be indicated when:
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SNF Regulations
Dose Reduction Requirements
• Within the first year in which a resident is admitted on an
antipsychotic medication or after the facility has initiated an
antipsychotic medication, the facility must attempt a GDR in
two separate quarters (with at least one month between the
attempts), unless clinically contraindicated.
• After the first year, a GDR must be attempted annually,
unless clinically contraindicated.
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Regulations- others
• ALF/SCALF
• Community practice
• Hospitals
– No current regulations governing antipsychotic
use. Future studies?
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Questions
?
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References
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Carnahan R, Reist J, Kelly M, et al. Antipsychotic Use in Dementia.
https://www.healthcare.uiowa.edu/IGEC/IAAdapt/document/Antipsychotic_Use_in_Dementia.pdf.
Accessed: 20 April 2012
Smith, Marianne. Algorithm for Treating Behavioral & Psychological Symptoms of Dementia.
https://www.healthcare.uiowa.edu/IGEC/IAAdapt/document/Algorithm_for_Treating_BPSD_Assessme
nt_and_Non-Drug_Management.pdf. Accessed: 20 April 2012
Powers. A short practical guide for psychotropic medications in dementia patents
Maher AR, Maglione M, Bagley S, et al. Efficacy and Comparative Effectiveness of Atypical
Antipsychotic Medications for Off-Label Uses in Adults. JAMA 2011;206(12):1359-1369
Schneider LS, Tariot PN, Dagerman KS, et al. Effectiveness of atypical antipsychotic drugs in patients
with Alzheimer’s disease. N Engl J Med. Oct 12 2006; 355(15):1525-1538.
Schneider, LS et al. Risk of death with atypical antipsychotic drug treatment for dementia: metaanalysis of randomized placebo-controlled trials. JAMA. 2005; 294:1934-194
Alexander, Michael; Larson, Eric B. “Patient Information: Dementia (including Alzheimer disease)
(Beyond the Basics)." UpToDate. DeKosky, Steven T. 2012. Accessed: 25 October 2012
<www.uptodate.com/contents/dementia-including-alzheimer-disease-beyond-the-basics>.
Facts & Comparisons. Facts & Comparisons Web site. http://online.factsandcomparisons.com.
Accessed: 25 October 2012 .
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001752/ Accessed: 25 October 2012
“Dementia: Antipsychotic Guide for Care Providers”
https://www.healthcare.uiowa.edu/IGEC/IAAdapt/pharmacist Accessed: 20 April 2012
“Drugs that may cause delirium or problem behaviors”
https://www.healthcare.uiowa.edu/IGEC/IAAdapt/pharmacist Accessed: 20 April 2012
State Operations Manual: Appendix PP- Guidance to Surveyors For Long Term Care Facilities. Rev. 130
12-12-2014
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